FDA-Device2021-08-18Class II
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
Advance Dx, Inc.
Hazard
Due to high glucose test results when using the blood collection cards.
Sold states
U.S. Nationwide distribution in the states of MD and NC.
Affected count
179,750 cards
Manufactured in
11250 N 118th Way, N/A, Scottsdale, AZ, United States
Products
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2021Don't want to check this manually?
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